Actively Recruiting

All Genders
NCT03057860

TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

Led by Technische Universität Dresden · Updated on 2022-05-09

2800

Participants Needed

3

Research Sites

569 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence. Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy. Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA). Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany). Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative. In this situation, clinical registries can provide valuable information for evidence-based clinical decision making. Extension of TREATgermany to children and adolescents is necessary as * moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood * it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone * innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria * adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group * Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care

CONDITIONS

Official Title

TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of atopic dermatitis according to the United Kingdom working party diagnostic criteria
  • Moderate to severe atopic dermatitis
  • Objective SCORAD greater than 20 or current anti-inflammatory systemic treatment for atopic dermatitis
  • Previous anti-inflammatory systemic treatment for atopic dermatitis within the past 24 months
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Clinics for Dermatology, Allergy and Venerology, Hannover Medical School

Hanover, Lower Saxony, Germany, 30625

Actively Recruiting

2

Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden

Dresden, Saxony, Germany, 01307

Actively Recruiting

3

Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany, 24105

Actively Recruiting

Loading map...

Research Team

J

Jochen Schmitt, Prof.Dr.

CONTACT

E

Eva Haufe, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here